Bioresorbable vascular scaffolds (BVS) were designed to improve late event-free survival compared with metallic drug-eluting stents. However, initial trials demonstrated worse early outcomes with ...BVS, in part due to suboptimal technique. In the large-scale, blinded ABSORB IV trial, polymeric everolimus-eluting BVS implanted with improved technique demonstrated noninferior 1-year outcomes compared with cobalt chromium everolimus-eluting stents (CoCr-EES).
This study sought to evaluate the long-term outcomes from the ABSORB IV trial.
We randomized 2,604 patients at 147 sites with stable or acute coronary syndromes to BVS with improved technique vs CoCr-EES. Patients, clinical assessors, and event adjudicators were blinded to randomization. Five-year follow-up was completed.
Target lesion failure at 5 years occurred in 216 (17.5%) patients assigned to BVS and 180 (14.5%) patients assigned to CoCr-EES (P = 0.03). Device thrombosis within 5 years occurred in 21 (1.7%) BVS and 13 (1.1%) CoCr-EES patients (P = 0.15). Event rates were slightly greater with BVS than CoCr-EES through 3-year follow-up and were similar between 3 and 5 years. Angina, also centrally adjudicated, recurred within 5 years in 659 patients (cumulative rate 53.0%) assigned to BVS and 674 (53.3%) patients assigned to CoCr-EES (P = 0.63).
In this large-scale, blinded randomized trial, despite the improved implantation technique, the absolute 5-year rate of target lesion failure was 3% greater after BVS compared with CoCr-EES. The risk period for increased events was limited to 3 years, the time point of complete scaffold bioresorption; event rates were similar thereafter. Angina recurrence after intervention was frequent during 5-year follow-up but was comparable with both devices.(Absorb IV Randomized Controlled Trial; NCT02173379)
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The aim of this study was to identify the determinants of plaque structural stress (PSS) and the relationship between PSS and plaques with rupture.
Plaque rupture is the most common cause of ...myocardial infarction, occurring particularly in higher risk lesions such as fibroatheromas. However, prospective intravascular ultrasound–virtual histology studies indicate that <10% higher risk plaques cause clinical events over 3 years, indicating that other factors also determine plaque rupture. Plaque rupture occurs when PSS exceeds its mechanical strength; however, the determinants of PSS and its association with plaques with proven rupture are not known.
We analyzed plaque structure and composition in 4,053 virtual histology intravascular ultrasound frames from 32 fibroatheromas with rupture from the intravascular ultrasound–virtual histology in Vulnerable Atherosclerosis study and 32 fibroatheromas without rupture on optical coherence tomography from a stable angina cohort. Mechanical loading in the periluminal region was estimated by calculating maximum principal PSS by finite element analysis.
PSS increased with increasing lumen area (r = 0.46; p = 0.001), lumen eccentricity (r = 0.32; p = 0.001), and necrotic core ≥10% (r = 0.12; p = 0.001), but reduced when dense calcium was ≥10% (r = −0.12; p = 0.001). Ruptured fibroatheromas showed higher PSS (133 kPa quartiles 1 to 3: 90 to 191 kPa vs. 104 kPa quartiles 1 to 3: 75 to 142 kPa; p = 0.002) and variation in PSS (55 kPa quartiles 1 to 3: 37 to 75 kPa vs. 43 kPa quartiles 1 to 3: 34 to 59 kPa; p = 0.002) than nonruptured fibroatheromas, with rupture primarily occurring either proximal or immediately adjacent to the minimal luminal area (87.5% vs. 12.5%; p = 0.001). PSS was higher in segments proximal to the rupture site (143 kPa quartiles 1 to 3: 101 to 200 kPa vs. 120 kPa quartiles 1 to 3: 78 to 180 kPa; p = 0.001) versus distal segments, associated with increased necrotic core (19.1% quartiles 1 to 3: 11% to 29% vs. 14.3% quartiles 1 to 3: 8% to 23%; p = 0.001) but reduced fibrous/fibrofatty tissue (63.6% quartiles 1 to 3: 46% to 78% vs. 72.7% quartiles 1 to 3: 54% to 86%; p = 0.001). PSS >135 kPa was a good predictor of rupture in higher risk regions.
PSS is determined by plaque composition, plaque architecture, and lumen geometry. PSS and PSS variability are increased in plaques with rupture, particularly at proximal segments. Incorporating PSS into plaque assessment may improve identification of rupture-prone plaques.
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The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened ...to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.
BACKGROUND—The incretin hormone glucagon-like peptide-1 (GLP-1) has been shown to have cardioprotective properties in animal models of ischemia and infarction due to promotion of myocardial glucose ...uptake and suppression of apoptosis. We investigated whether GLP-1 protected the heart from dysfunction caused by supply ischemia during percutaneous coronary intervention (PCI).
METHODS AND RESULTS—Twenty patients with normal left ventricular (LV) function and single-vessel coronary disease within the left anterior descending artery undergoing elective PCI were studied. A conductance catheter was placed into the LV through the femoral artery, and pressure-volume loops were recorded at baseline and during a 1-minute low-pressure balloon occlusion at the site of the stenosis. The patients were randomized to receive an infusion of either GLP-1(7–36) amide at 1.2 pmol/kg per minute or saline immediately after the first balloon occlusion. Coronary balloon occlusion caused LV stunning in the control group with cumulative LV dysfunction on subsequent occlusion that was not seen in the GLP-1 group. GLP-1 improved recovery of LV systolic and diastolic function at 30 minutes after balloon occlusion compared with control (delta dP/dtmax from baseline, −1.6% versus −12.2%; P=0.02) and reduced the LV dysfunction after the second balloon occlusion (delta dP/dtmax, −13.1% versus −25.3%; P=0.01).
CONCLUSIONS—In this pilot study, infusion of GLP-1 has been demonstrated to reduce ischemic LV dysfunction after supply ischemia during coronary balloon occlusion in humans and mitigates stunning. The findings require confirmation in a larger scale clinical trial.
CLINICAL TRIAL REGISTRATION—URLhttp://www.isrctn.org. Unique identifierISRCTN 77442023.
In the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent ...expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact on clinical outcomes is unknown. The aim of the present study was to report the 12-month clinical follow-up data from the ILUMIEN III study.
OCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes among the groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT.
In this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12 months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit of OCT-guided PCI.
NCT02471586.
Objectives
To investigate the impact of minimal stent area (MSA) evaluated by post‐procedural intravascular ultrasound (IVUS) on clinical outcomes after contemporary PCI in patients with three‐vessel ...disease (TVD).
Background
The impact of post‐procedural MSA on clinical outcomes has not yet been extensively studied in patients with TVD.
Methods
The SYNTAX II study is a multicenter, all‐comers, open‐label, single arm study that investigated the impact of a state‐of‐the‐art PCI strategy on clinical outcomes in patients with TVD (454 patients with 1,559 lesions). The relationships between post‐procedural MSA and lesion‐level outcomes at 2 years were investigated. Clinical events adjudicated per patient by clinical event committee were assessed per lesion. Lesion‐oriented composite endpoint (LOCE) was defined as the composite of cardiac death, target‐vessel myocardial infarction, and ischemia‐driven target lesion revascularization.
Results
Eight hundred and nineteen lesions with post‐procedural MSA available in 367 patients were included in the analysis. The post‐procedural MSA per lesion was divided into terciles (smallest tercile: ≤5.0 mm2, intermediate tercile: 5.0–6.7 mm2, and largest tercile: >6.7 mm2). LOCE was observed in 16/288 (5.6%), 15/265 (5.7%), and 8/266 (3.0%) (P = 0.266). Target lesion revascularization (TLR) was observed in 16/288(5.6%), 12/265 (4.5%), and 4/266 (1.5%) (P = 0.042). The multivariate analysis demonstrated that smaller post‐procedural MSA, as well as creatinine clearance, history of previous stroke, chronic total occlusion, and lesion SYNTAX Score was an independent predictor of TLR.
Conclusions
In the SYNTAX II trial, larger post‐procedural MSA was independently associated with the lower rate of TLR at 2 years.
Although extensive clinical data support the utility of intravascular imaging to guide and optimize outcomes following percutaneous coronary interventions (PCI), clinical adoption remains limited. ...One of the primary reasons for limited utilization may be a lack of standardization on how to best integrate the data provided by intravascular imaging practically. Optical coherence tomography (OCT) offers a high‐resolution intravascular imaging modality with integrated software automation that allows for incorporation of OCT into the routine workflow of PCIs. We suggest use of an algorithm called MLD MAX to incorporate OCT for imaging‐guided interventions: the baseline OCT imaging run is intended to facilitate procedural planning and strategizing, consisting of assessment for predominant lesion morphology (M), measurement for stent length (L) and determination of stent diameter (D); the post‐PCI OCT imaging run is designated for assessment of need for further optimization of stent result, and consists of analysis for medial dissections (M), adequate stent apposition (A) and stent expansion (X). Incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily‐memorable workflow for optimized PCI procedures.
Although rupture of thin-cap fibroatheroma (TCFA) underlies most myocardial infarctions, reliable TCFA identification remains challenging. Virtual-histology intravascular ultrasound (VH-IVUS) and ...optical coherence tomography (OCT) can assess tissue composition and classify plaques. However, direct comparisons between VH-IVUS and OCT are lacking and it remains unknown whether combining these modalities improves TCFA identification.
Two hundred fifty-eight regions-of-interest were obtained from autopsied human hearts, with plaque composition and classification assessed by histology and compared with coregistered ex vivo VH-IVUS and OCT. Sixty-seven regions-of-interest were classified as fibroatheroma on histology, with 22 meeting criteria for TCFA. On VH-IVUS, plaque (10.91±4.82 versus 8.42±4.57 mm(2); P=0.01) and necrotic core areas (1.59±0.99 versus 1.03±0.85 mm(2); P=0.02) were increased in TCFA versus other fibroatheroma. On OCT, although minimal fibrous cap thickness was similar (71.8±44.1 μm versus 72.6±32.4; P=0.30), the number of continuous frames with fibrous cap thickness ≤85 μm was higher in TCFA (6.5 1.75-11.0 versus 2.0 0.0-7.0; P=0.03). Maximum lipid arc on OCT was an excellent discriminator of fibroatheroma (area under the curve, 0.92; 95% confidence interval, 0.87-0.97) and TCFA (area under the curve, 0.86; 95% confidence interval, 0.81-0.92), with lipid arc ≥80° the optimal cut-off value. Using existing criteria, the sensitivity, specificity, and diagnostic accuracy for TCFA identification was 63.6%, 78.1%, and 76.5% for VH-IVUS and 72.7%, 79.8%, and 79.0% for OCT. Combining VH-defined fibroatheroma and fibrous cap thickness ≤85 μm over 3 continuous frames improved TCFA identification, with diagnostic accuracy of 89.0%.
Both VH-IVUS and OCT can reliably identify TCFA, although OCT accuracy may be improved using lipid arc ≥80° and fibrous cap thickness ≤85 μm over 3 continuous frames. Combined VH-IVUS/OCT imaging markedly improved TCFA identification.
Lower-limb amputation rates in patients with chronic limb-threatening ischemia vary across the United States, with marked disparities in amputation rates by gender, race, and income status. We ...evaluated the association of patient, hospital, and geographic characteristics with the intensity of vascular care received the year before a major lower-limb amputation and how intensity of care associates with outcomes after amputation.
Using Medicare claims data (2016-2019), beneficiaries diagnosed with chronic limb-threatening ischemia who underwent a major lower-limb amputation were identified. We examined patient, hospital, and geographic characteristics associated with the intensity of vascular care received the year before amputation. Secondary objectives evaluated all-cause mortality and adverse events following amputation.
Of 33 036 total Medicare beneficiaries undergoing major amputation, 7885 (23.9%) were due to chronic limb-threatening ischemia; of these, 4988 (63.3%) received low-intensity and 2897 (36.7%) received high-intensity vascular care. Mean age, 76.6 years; women, 38.9%; Black adults, 24.5%; and of low income, 35.2%. After multivariable adjustment, those of low income (odds ratio, 0.65 95% CI, 0.58-0.72;
<0.001), and to a lesser extent, men (odds ratio, 0.89 95% CI, 0.81-0.98;
=0.019), and those who received care at a safety-net hospital (odds ratio, 0.87 95% CI, 0.78-0.97;
=0.012) were most likely to receive low intensity of care before amputation. High-intensity care was associated with a lower risk of all-cause mortality 2 years following amputation (hazard ratio, 0.79 95% CI, 0.74-0.85;
<0.001).
Patients who were of low-income status, and to a lesser extent, men, or those cared for at safety-net hospitals were most likely to receive low-intensity vascular care. Low-intensity care was associated with worse long-term event-free survival. These data emphasize the continued disparities that exist in contemporary vascular practice.
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